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Assessing the effects of an educational intervention for chronic disease management in rural China

Condition category

Nutritional, Metabolic, Endocrine

Date applied

22/03/2017

Date assigned

04/04/2017

Last edited

24/03/2017

Prospective/Retrospective

Retrospectively registered

Overall trial status

Ongoing

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsChina is facing a serious situation with the increasing prevalence of chronic (long-term) diseases. According to the report published by National Health and Family Planning Commission in 2015, 19% of the population in China suffers from different kinds of chronic diseases. Moreover, the country’s previous strategy for chronic disease management has focused on the much more costly hospital care, instead of primary care and self-management in rural areas. High health expenses still prevail, which may also increase the economic burden on patients and influence health care seeking behavior. Hence, new strategies are needed to improve treatment of chronic diseases in rural areas. Currently, different outcomes have been used to test the effects of chronic disease management strategies. Despite an increasing number of studies focusing on type 2 diabetes (T2DM) and high blood pressure (hypertension) management in China, most have been performed in urban areas. Moreover, most researchers test physical outcomes, but other important outcomes such as the patient’s perspective, health care seeking behaviour, and the knowledge of healthcare professionals are ignored. The aim of this study is to improve the care of patients with T2DM and hypertension in rural areas through an educational intervention directed at healthcare professionals, to shift the care of patients with T2DM and hypertension from hospital to primary care services.

Who can participate? Patients aged 35-75 with T2DM or primary hypertension and health care professionals from the participating counties, townships and village clinics

What does the study involve?The participating areas are divided into different groups according to economic status and health development, and then two areas are randomly selected from each group: one to the intervention group and one to the control group. Patients in the intervention areas receive services including lectures about self-management strategies, follow-up interviews, physical examination, and special medical services (such as medical treatment, transfer treatment, return visits, and clinical care). The healthcare professionals in the intervention groups are provided with professional development including training lessons, regular meetings, team communications, technical checks, and new performance appraisal. For patients and healthcare professionals in the control areas, current routine health services continue as usual. The patients' blood glucose, blood pressure, health status, satisfaction with health services, health insurance, understanding of diabetes, health seeking behaviour, and out-of-pocket costs of care are assessed before and after the intervention. The health care professionals' knowledge about chronic disease management and their general perceptions about the intervention are assessed before and after the intervention.

What are the possible benefits and risks of participating? Patients in the intervention areas benefit from receiving information and guidance in issues related to chronic diseases and self-management. Health care professionals who are participating in the intervention may benefit from the possibility of being offered a promotion. Moreover, the intervention contains a performance appraisal, including a bonus and professional development for healthcare professionals. A potential risk for the patients is the leak of information as some sensitive data is collected. In order to reduce the risk of a leak, all members of the research team are asked to sign a confidentiality agreement. There are no risks for healthcare professionals participating in the study.

Where is the study run from?The study is conducted in three counties in Jiangsu province (Gaochun, Jingjiang, Huaiyin) together with the township health centers and villages clinics in those townships. In total, 22 township health centers are involved in the study. The whole process is led by the research team and coordinated by the local health bureau.

When is the study starting and how long is it expected to run for? January 2015 to December 2018

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Vertical integrated service model: an educational intervention for chronic disease for patients and healthcare professionals in rural China

Acronym

Study hypothesis

1. The education-based intervention will have a positive effect on the patients’ physical health and their understanding of their chronic disease.2. The educational intervention will improve the professionalism and understanding of chronic disease management for local healthcare professionals.

Ethics approval

Nanjing Medical University Ethics Committee, 02/08/2015, ref: 300

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in English, please use the contact details to request a patient information sheet

Condition

Intervention

The project is an interventional study conducted in three counties in Jiangsu Province, China. The selection of intervention and control groups is done by the local (township level) health bureaus. They will firstly divide the townships into different groups according to economic status and health development, and then randomly select two townships (one as intervention, one as control) from each group.

The educational intervention will be conducted by a service team which has been assembled by the local health bureau in each county.

Patients in the intervention group will receive the following services:1. Lectures mainly focusing on prevention and self-management strategies for chronic disease, nutrition and physical activity, proper health behaviours, and psychological counselling2. Periodical follow-up interviews along with an annual physical examination3. Special medical service, including helping patients with medical treatment, transfer treatment, return visit, and clinical care, etc

Healthcare professionals in the intervention group will receive the following services:1. Training lessons for the village GPs.2. Regular meetings to discuss their work progress3. Team communications about analysing patients’ conditions or formulating personalized therapeutic regimens4. Technical checks to inspect the patients’ disease monitoring schemes, prevention and treatment plans5. New performance appraisal for doctors and nurses containing two parts:5.1. Bonus for those who do well in the project5.2. Opportunities for professional development for outstanding doctors or nurses

For patients and healthcare professionals in the control areas, current routine health services will continue as usual and there will be no service team.

The intervention will last for one year in two counties and for two years in the third county. During this period, the county level and township level health bureaus will be responsible for administrating the whole process. The research team will conduct periodical quality controls.

Secondary outcome measures

For healthcare professionals: 1. Knowledge about the current epidemiological situation of chronic disease in their own village, assessed through a knowledge test2. The general procedure of diagnosing and registering chronic disease, assessed through in-depth interviews3. The chronic disease management situation before and after intervention, assessed through in-depth interviews4. Their general perceptions about the intervention, assessed through in-depth interviewsMeasured at baseline and follow-up (12 months after start of intervention)

Overall trial start date

01/01/2015

Overall trial end date

30/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with type 2 diabetes (FBG ≥7.0 mmol/l, and/or 2hPBG ≥11.1 mmol/l) or primary hypertension (SBP ≥140mmHg, and/or DBP ≥90mmHg) and has been on medications for more than one month2. Aged 35-753. Lived in the intervention/control areas for more than two years (no records of moving within the last year)4. Has no plan of moving from the intervention/control areas or no long-term travelling plans (more than one year)5.Has his/her records on the chronic disease management information system of township health center or village clinic, and has accepted the chronic disease service provided by township health center or village clinic6. Willing to participate in this project and has a preferable compliance, cognition and receptivity

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

1,980

Participant exclusion criteria

1. Has serious complications of diabetes or hypertension (for example, diabetic foot III/IV, diabetic retinopathy IV or higher, diabetic nephropathy IV/V, hypertension III)2. Has been diagnosed with secondary hypertension3. Has been diagnosed with any other serious disease, such as terminal stages of cancer, AIDS, etc4. Pregnant women or patients with psychiatric problems

Sponsor information

Organisation

Sponsor details

Sponsor type

Website

Funders

Funder type

Government

Funder name

National Natural Science Fund of China

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in high-impact peer reviewed journals as well as Chinese core journals (in total 6-10 papers). Moreover, 4-8 policy advisory reports to different Chinese governmental departments as well as 4 research reports will be provided.

IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Dongfu Qian (dqian@njmu.edu.cn)